Toe orthosis

ABSTRACT

An orthosis configured to stretch tissue around an ankle joint of a patient and methods for assembling and using the same are provided. The orthosis includes a first member affixable to a lower leg of the patient, a second member affixable to a foot of the patient, the second member including a second extension member having an arcuate shape configured to move along an arcuate path relative to the first member when the second member is moved from a first position to a second position relative to the first member, and a drive assembly coupled to the first member and the second member, the drive assembly configured to move the second member with respect to the first member.

CROSS-REFERENCE TO RELATED APPLICATION

This patent application is a continuation application of U.S. patentapplication Ser. No. 14/324,365, filed on Jul. 7, 2014 (now U.S. Pat.No. 9,237,962), which is a continuation application of U.S. patentapplication Ser. No. 13/585,917, filed on Aug. 15, 2012 (now U.S. Pat.No. 8,771,211), which is a continuation application of U.S. patentapplication Ser. No. 11/686,989 filed on Mar. 16, 2007 (now U.S. Pat.No. 8,251,935), which claims priority from U.S. Provisional PatentApplication Ser. No. 60/783,248, filed on Mar. 17, 2006, the contents ofwhich are herein incorporated by reference in its entirety.

FIELD OF THE DISCLOSURE

The present disclosure relates to an adjustable orthosis for stretchingtissue in the human body. In particular, the present disclosure relatesto an adjustable orthosis which can be used for stretching tissue suchas ligaments, tendons or muscles around a joint during flexion orextension of the joint.

BACKGROUND

In a joint, the range of motion depends upon the anatomy of that jointand on the particular genetics of each individual. Typically, jointsmove in two directions, flexion and extension. Flexion is to bend thejoint and extension is to straighten the joint; however, in theorthopedic convention some joints only flex. For example, the ankle hasdorsiflexion and plantarflexion. Other joints not only flex and extend,they rotate. For example, the elbow joint has supination and pronation,which is rotation of the hand about the longitudinal axis of the forearmplacing the palm up or the palm down.

When a joint is injured either by trauma or by surgery, scar tissue canform, often resulting in flexion or extension contractures. Suchconditions can limit the range of motion of the joint, limiting flexion(in the case of an extension contracture) or extension (in the case of aflexion contracture) of the injured joint. It is often possible tocorrect this condition by use of a range-of-motion (ROM) orthosis.

ROM orthoses are devices commonly used during physical rehabilitativetherapy to increase the range-of-motion over which the patient can flexor extend the joint. Commercially available ROM orthoses are typicallyattached on opposite members of the joint and apply a torque to rotatethe joint in opposition to the contraction. The force is graduallyincreased to increase the working range or angle of joint motion.Exemplary orthoses include: U.S. Pat. No. 6,599,263, entitled “ShoulderOrthosis;” U.S. Pat. No. 6,113,562, entitled “Shoulder Orthosis;” U.S.Pat. No. 5,848,979, entitled “Orthosis;” U.S. Pat. No. 5,685,830,entitled “Adjustable Orthosis Having One-Piece Connector Section forFlexing;” U.S. Pat. No. 5,611,764, entitled “Method of Increasing Rangeof Motion;” U.S. Pat. No. 5,503,619, entitled “Orthosis for BendingWrists;” U.S. Pat. No. 5,456,268, entitled “Adjustable Orthosis;” U.S.Pat. No. 5,453,075, entitled “Orthosis with Distraction through Range ofMotion;” U.S. Pat. No. 5,395,303, entitled “Orthosis with Distractionthrough Range of Motion;” U.S. Pat. No. 5,365,947, entitled “AdjustableOrthosis;” U.S. Pat. No. 5,285,773, entitled “Orthosis with Distractionthrough Range of Motion;” U.S. Pat. No. 5,213,095, entitled “Orthosiswith Joint Distraction;” and U.S. Pat. No. 5,167,612, entitled“Adjustable Orthosis;” U.S. patent application Ser. No. 11/261,424entitled “Range of Motion Device;” and PCT International Application No.PCT/US06/60228 entitled “Range of Motion Device,” all to Bonutti andherein are expressly incorporated by reference in their entirety

SUMMARY

The present disclosure provides an ankle orthosis for stretching theconnective tissue around an ankle joint of a patient. An ankle jointdefines on one side of the joint an inner sector which decreases inangle as the joint is flexed in a first direction (dorsiflexion) and onthe opposite side of the joint an outer sector which decreases in angleas the joint is flexed in second direction (plantarflexion).

The orthosis includes a first member affixable to a lower leg of thepatient. A second member is affixable to a foot of the patent, where theheel of the foot is free floating. The first member includes a firstextension member which defines an arcuate channel therein. The second amember has a second extension member having an arcuate shape extendingthere from. The second and first extension members are operativelyconnected, such that the second extension member travels through arcuatechannel of the first extension member when the second member is movedfrom a first position to a second position relative to the first member.

The orthosis further includes a drive assembly for selectively movingthe second extension member relative to the first extension member. Thedrive assembly is mounted onto the first extension member, engaging thesecond extension member. The drive assembly can be manually orautomatically actuated to selectively move the second extension memberrelative to the first extension member.

BRIEF DESCRIPTION OF THE DRAWINGS

A more complete understanding of the present disclosure, and theattendant advantages and features thereof, will be more readilyunderstood by reference to the following detailed description whenconsidered in conjunction with the accompanying drawings wherein:

FIG. 1 depicts an isometric view of an orthosis of the presentdisclosure;

FIG. 2 depicts an isometric view of a first member of the orthosis ofFIG. 1;

FIG. 3 depicts a sectional side view of the first member of FIG. 2;

FIG. 4 depicts a partial sectional view of the first member of FIG. 2;

FIG. 5 depicts an isometric view of a second member of the orthosis ofFIG. 1;

FIG. 6 depicts a sectional view of the orthosis of FIG. 1;

FIG. 7 depicts an alternative drive assembly of the orthosis of FIG. 1;

FIG. 8 depicts a side view of the drive assembly of FIG. 7;

FIG. 9 depicts a rear side partial isometric view of the drive assemblyof FIG. 7;

FIG. 10 depicts another orthosis of the present disclosure;

FIG. 11 depicts a sectional view of a first member of the orthosis ofFIG. 10;

FIG. 12 depicts a sectional view of the drive assembly of the orthosisof FIG. 10;

FIG. 13 depicts a partial sectional view of the orthosis of FIG. 10;

FIG. 14 depicts a foot plate of the orthosis of FIG. 10;

FIG. 15 depicts the orthosis of FIG. 10 including a toe assembly;

FIG. 16 depicts a front isometric view of the toe assembly;

FIG. 17 depicts a side isometric view of the toe assembly;

FIG. 18 depicts the drive assembly of the toe assembly;

FIG. 19 depicts the toe cuff of the toe assembly;

FIG. 20 is an exploded view of the drive assembly connection to thefirst member of the toe assembly;

FIG. 21 is a top view of the drive assembly of the toe assembly;

FIG. 22 is an exploded view of another drive assembly connection to thefirst member of the toe assembly;

FIG. 23 depicts a bottom view of the toe assembly; and

FIG. 24 depicts a bottom view of a first cuff of the toe assembly.

DETAILED DESCRIPTION

The present disclosure relates to an orthosis for moving a joint betweenfirst and second relatively pivotable body portions. A joint and thefirst and second body portions can define on one side of the joint aninner sector which decreases in angle as the joint is flexed in a firstdirection (dorsiflexion) and on the opposite side of the joint an outersector which decreases in angle as the joint is flexed in seconddirection (plantarflexion).

The orthosis of the present disclosure includes a drive assembly formoving the second body portion with respect to the first body portionfrom a first position to a second position. The orthosis fully or atleast partially restricts motion of the second body portion in at leastone direction utilizing the principles of stress relaxation to stretchthe tissue around the joint.

After a set time period, the drive assembly may be used to move thesecond body portion from the second position to a third position,incrementally stretching the tissue surrounding the joint. Thus, theorthosis may be capable of moving from a first position to one or moreother positions to provide different configuration angles of the device.It is contemplated that the drive assembly may be used to incrementallymove the second body portion after the expiration of a predeterminedtime or until completion of the protocol. This approach is differentfrom application of a constant load over a sustained time period.

Referring now to the figures in which like reference designators referto like elements, there is shown in FIG. 1 an orthosis 10 of the presentinvention. The orthosis 10 includes a first member 12 attachable to afirst body portion, such as a user's lower leg. The shape andconfiguration of the first member 12 may be selected to support orconform generally along the lower leg of the user.

The first member 12 is operatively associated with or connected to asecond member 14 so that the first and second members 12 and 14 may moveor rotate with respect to each other. In use, the second member 14 maybe attachable to a second body portion, such as a foot, so that therelative movement of the two members 12 and 14 also causes movement ofthe ankle joint. The orthosis 10 may have an axis of rotation 16 that isaligned with the axis of rotation of the joint. In this manner, theinstantaneous axis of rotation (IAR) of the first and second members 12and 14 may better match the IAR of the treated joint. The first andsecond members 12 and 14 are operatively connected to each other, offsetfrom the orthosis axis 16.

The first member 12 of the orthosis 10 includes a first extension member18 extending there from and having an arcuate shape. The second member14 of the orthosis 10 likewise includes a second extension member 20extending therefore and having an arcuate shape. The first and secondextension members 18 and 20 are operatively connected at point “P,” suchthat in operation the second extension member 20 travels through thefirst extension member 18 about an arcuate path and substantiallythrough point “P.” The arcuate shapes of the first and second extensionmembers 18 and 20 result in the foot rotating about the orthosis axis16, or alternatively about a moving IAR, when the second member 14 ismoved from a first position to a second position relative to the firstmember 12, thereby preventing compression of the joint.

The orthosis 10 further includes a drive assembly 22, which isillustrated in FIG. 1 at or near point “P.” In this embodiment, thedrive assembly 22 is operably connected to the first and secondextension members 18 and 20 for applying force to the first and secondmembers 12 and 14 to pivot the second body portion about the orthosisaxis 16. As will be shown below in additional embodiments, the driveassembly 22 may be configured or disposed to interact with or operate onone of the first or second members 12 and 14 independently.

Referring to FIG. 2, in order for the orthosis 10 to flex the joint thefirst and second members 12 and 14 are affixed to the first and secondbody portions, respectively, tightly enough so that the first and secondmembers 12 and 14 can apply torque to flex the joint. The attachments ofthe first and second body portions to the first and second members 12and 14, allow the heel or the foot to be free-floating within theorthosis, thereby preventing heel lift-off during operation of theorthosis 10. The second extension member 20 is moved through the driveassembly 22 from a first position to a second position, relative to thefirst extension member 18, rotating the second member 14 and the secondbody portion about the orthosis axis 16 stretching the joint. As thesecond member 14 is rotated to the second position, the second extensionmember 20 travels at least partially through point “P” and may travelsubstantially through this point for a large range of motion. Becausethe first and second members 12 and 14 are affixed to the first andsecond body portions, the outward pivoting movement of the second member14 causes the joint to be flexed as desired. The orthosis 10 may then bemaintained in the second position for a predetermined treatment timeproviding a constant stretch to the joint. The orthosis 10 mayalternatively be configured to impart a constant force or load on thejoint or may utilize the techniques of Static Progressive Stretch asdescribed in co-pending application Ser. No. 11/203,516, entitled “RANGEOF MOTION SYSTEM AND METHOD,” and filed on Aug. 12, 2005, the entiretyof which is incorporated by reference.

Returning to the example where the orthosis is maintained in the secondposition, after the expiration of the treatment time, the second member14 may then be moved back to the first position, relieving the joint.Optionally, the second member 14 can be rotated to a third position,increasing the stretch on the joint, or partially reducing it to allowlimited relaxation of the surrounding tissue. The second member 14 canbe rotated at discrete time intervals to incrementally increase, reduce,or vary the stretch of the joint through the treatment cycle. Aftercompletion of the treatment cycle, the second member 14 is returned tothe first position for removal of the orthosis 10. In operation, theorthosis 10 can be utilized to flex the joint in either dorsiflexion orplantarflexion.

Referring to FIGS. 2 and 3, the first member 12 includes a pair ofstraps 24 attachable about a user's lower leg. The straps 24 aresufficiently tighten to prevent relative movement between the firstmember 12 and the lower leg. The first extension member 18 portion ofthe first member 12 includes an arcuate main channel 28 extendingtherein. A cover plate 26 is affixable to the first extension member 18,over the main channel 28, defining a passage through which the secondextension member 20 travels. The first extension member 18 can furtherinclude a base 30, where the base 30 is configured to support theorthosis 10 on a flat surface.

Referring also to FIG. 4, the drive assembly 22 is positioned in thefirst extension member 18 portion of the first member 12, proximal tothe base 30. The drive assembly 22 includes a drive gear 32 and a maingear 34, where the teeth of the drive gear 32 engage the teeth of themain gear 34. A drive shaft 36 is connected to the drive gear 32,extending through the cover plate 26. A knob 38 can be affixed to thedrive shaft 36 to facilitate rotation thereof. A rotation of the diveshaft 36 rotates the drive gear 32, which in turn rotates the main gear34. The main gear 34 is sized such that a portion of the gear teeth 40protrudes into the main channel 28 of the first extension member 18. Thegear teeth 40 sufficiently protrude into the main channel 28, such thatthe gear teeth 40 can engage the second extension member 20.

The drive mechanism 22 can further include a locking mechanism. Thelocking mechanism can be used to secure the position of the secondmember 14 with respect to the first member 12. The locking mechanism canprevent the actuation of the drive mechanism 22, securing the positionof first and second members 12 and 14. Alternatively, the lockingmechanism can secure the first and second members 12 and 14, preventingan actuation of the drive mechanism 22 from moving the first and secondmembers 12 and 14. The locking mechanism can be utilized such that theorthosis 10 can be used as a static splint.

Referring to FIGS. 5 and 6, the second extension member 20 of the secondmember 14 includes an upper surface 42, where the upper surface 42 caninclude a plurality of teeth (not shown). The teeth are sized such thatthe gear teeth 40 of the main gear 34 can engage the upper surface 42 ofthe second extension member 20 to move the second extension member 20through the arcuate passage in the first extension member 18 as the knob38 is rotated.

The second member 14 can include a foot plate 44 slidingly mountedthereon. For example, the second member 14 can include a slotted section48. A foot plate mounting bracket 46 is slidingly positioned on thesecond member 14, about the slotted section 48. Pins 50 are appliedthrough the mounting bracket 46 to secure the mounting bracket 46 in theslotted section 48. The foot plate 44 can further include a strap 52attachable about a user's foot. The strap 52 is sufficiently tightenedto prevent relative movement between the foot plate 44 and the foot. Theslidingly mounting of the foot plate 44 to the second member permits thefoot plate to be adjustable to accommodate various size feet.

In an exemplary use, the orthosis 10 is operated to flex a joint indorsiflexion in the following manner. The first member 12 is fastened tothe lower leg and the second member 14 is fastened to the foot. Theorthosis 10 is attached to the lower leg and foot in a first position.The drive assembly 22 is operated to move the second member 14 from thefirst position to a second position, relative to the first member 12 byrotating the foot about a joint axis 16, where the second extensionmember 20 in drawn in the arcuate passage of the first extension member18. The connective tissue of the joint is consequently stretched. Theorthosis 10 is maintained in the second position for a predeterminedtreatment time, utilizing the principles of stress relaxation to stretchthe connective tissue of the joint. Additionally, the second extensionmember 20 can be made of a substantially rigid but flexible material,such that while in the second position the second extension member 20acts like a spring, providing dynamic stretch to the connective tissueof the joint. After the expiration of the treatment time, the secondmember 14 may be returned to the first position, relieving the joint.

Optionally, the second member 14 can be rotated to a third position,further increasing the stretch of the connective tissue of the joint.The second member 14 can be rotated at discrete time intervals toincrementally increase the stretch of the joint through the treatmentcycle. After completion of the treatment cycle, the second member 14 isreturned to the first position relieving the joint.

In an exemplary use, the orthosis 10 is operated to flex a joint inplantarflexion in the following manner. The first member 12 is fastenedto the lower leg and the second member 14 is fastened to the foot. Theorthosis 10 is attached to the lower leg and foot in a first position.The drive assembly 22 is operated to move the second member 14 from thefirst position to a second position, relative to the first member 12 byrotating the foot about a joint axis 16, where the second extensionmember 20 is extended from the arcuate passage of the first extensionmember 18. The connective tissue of the joint is consequently stretched.The orthosis 10 is maintained in the second position for a predeterminedtreatment time, utilizing the principles of stress relaxation to stretchthe connective tissue of the joint. Additionally, the second extensionmember 20 can be made of a substantially rigid but flexible material,such that while in the second position the second extension member 20acts like a spring, providing dynamic stretch to the connective tissueof the joint. After the expiration of the treatment time, the secondmember 14 may be returned to the first position, relieving the joint.

Optionally, the second member 14 can be rotated to a third position,further increasing the stretch of the connective tissue of the joint.The second member 14 can be rotated at discrete time intervals toincrementally increase the stretch of the joint through the treatmentcycle. After completion of the treatment cycle, the second member 14 isreturned to the first position relieving the joint.

Referring to FIGS. 7 and 8, in another embodiment, the orthosis caninclude an alternative drive assembly 53. In the alternative driveassembly 53, the first member 12 includes a drive belt channel 54 havingupper and lower end portions 56 and 58. The drive assembly 53 ispositioned in the drive belt channel 54, where a drive gear 32 and amain gear 34 are positioned in the lower end portion 58 of the drivebelt channel 54. Referring also to FIG. 9, a lower belt gear 60 isoperable connected to the drive gear 32, such that drive gear 32 rotateswith the lower belt gear 60. An upper belt gear 62 is positioned in theupper end portion 56 of the drive belt channel 54, where a drive shaft64 is connected to the upper belt gear 62, extending through the coverplate 26. A knob 66 can be affixed to the drive shaft 64 to facilitaterotation thereof.

A drive belt 68 is positioned in the drive belt channel 54, about theupper and lower belt gears 60 and 62. A rotation of the dive shaft 64rotates the upper belt gear 62, which in turn drives the drive belt 68about the lower belt gear 60, rotating the drive gear 32 and the maingear 34. As previously described, the main gear 34 is sized such that aportion of the gear teeth 40 protrudes into the main channel 28 of thefirst extension member 18. The gear teeth 40 sufficiently protrude intothe main channel 28, such that the gear teeth 40 can engage the secondextension member 20. The inclusion of the drive belt 68 enables theposition of the knob 66 to be moved to an upper end portion of the firstextension member 18, decreasing the reaching distance for operating theorthosis 10. However, it is contemplated that the knob 66 can beoptionally located to either the upper position, attached to the upperbelt gear 60, or the lower position, attached to the drive gear 32, atthe discretion of the user.

The drive mechanism 53 can further include a locking mechanism. Thelocking mechanism can be used to secure the position of the secondmember 14 with respect to the first member 12. The locking mechanism canprevent the actuation of the drive mechanism 53, securing the positionof first and second members 12 and 14. Alternatively, the lockingmechanism can secure the first and second members 12 and 14, preventingan actuation of the drive assembly 22 from moving the first and secondmembers 12 and 14. The locking mechanism can be utilized such that theorthosis 10 can be used as a static splint.

In an alternative embodiment, the drive assembly 22 of orthosis 10 inaccordance with the present disclosure can be actuated by a motorinstead of by a manually actuatable member, such as the knob 38.Likewise, the motor may be configured an adapted with gearing thatcauses the orthosis to cycle through a range of motion in apredetermined manner, or alternatively maybe controlled by aprogrammable logic controller (PLC).

In an embodiment, an electric motor is mounted to the drive shaft 36 forrotation of the drive gear 32. A battery or other source of energyprovides electric power to the motor. Alternatively, the motor can besupplied with external power. A microprocessor controls the operation ofthe motor. The microprocessor and motor together can be used to cyclethe second member 14 through a plurality of positions that cause thejoint to undergo a range of motion, either by dorsiflexion, byplantarflexion, or both. For example, the microprocessor may be used tomove the second member 14 in one pivotal direction a certain amount,hold there while tissue stretches, then move further in that direction;or in any other manner.

In another manner of use, the orthosis 10 can be set to cycle to one endof the joint's range of motion and hold there for a predetermined periodof time, then cycle to the other end of the joint's range of motion andhold there. The programming and control of the microprocessor is withinthe skill of the art as it relates to driving the motor to control thesecond member 14 to move in known manners. This embodiment is ideallysuited for continuous passive motion exercise, because the orthosis 10is portable and because the motor can be programmed with the desiredsequence of movements.

It should be understood that the particular physical arrangement of themotor, the power source, and the microprocessor is not the only possiblearrangement of those elements. The disclosure contemplates that otherarrangements of these or similarly functional elements are quitesuitable, and thus, the disclosure is intended to cover any sucharrangement. Additionally, another type of power source, other than anelectric motor, can also be used. For example, the use of a hydraulic orpneumatic motor as the drive assembly is contemplated.

The present disclosure can further include a monitor for use with theorthosis 10, which provides assurances the patient is properly using theorthosis 10 during his/her exercise period. For instance, the monitorcan have a position sensor, a temperature sensor, a force sensor, aclock or timer, or a device type sensor for monitoring the patient'simplementation of a protocol. The information obtained from thesemonitoring devices may be stored for later analysis or confirmation ofproper use or may be transmitted in real-time during use of the device.The data obtained from the monitor can be analyzed by a healthcareprofessional or technician and the protocol can be adjusted accordingly.

This analysis may be conducted remotely, thereby saving the time andexpense of a home visit by a healthcare professional or technician. Anexemplary monitoring system is provided in U.S. Publication No.20040215111 entitled “Patient Monitoring Apparatus and Method forOrthosis and Other Devices,” to Bonutti et al., the content of which isherein expressly incorporated by reference in its entirety.

Referring to FIG. 10, another embodiment of the orthosis 80 of thepresent disclosure is provided. The orthosis 80 includes a first member82 attachable to a first body portion, such as a user's lower leg. Theshape and configuration of the first member 82 may be selected tosupport or conform generally along the lower leg of the user.

The first member 82 is operatively associated with or connected to asecond member 84 so that the first and second members 82 and 84 may moveor rotate with respect to each other. In use, the second member 84 maybe attachable to a second body portion, such as a foot, so that therelative movement of the two members 82 and 84 also causes movement ofthe ankle joint. The orthosis 80 may have an axis or rotation 86 that isaligned with the axis of rotation of the joint. In this manner, theinstantaneous axis of rotation (IAR) of the first and second members 82and 84 may better match the IAR of the treated joint. The first andsecond members 82 and 84 are operatively connected to each other, offsetfrom the orthosis axis 86.

The first member 82 of the orthosis 80 includes a first extension member88 extending there from and having an arcuate shape. The second member84 of the orthosis 80 likewise includes a second extension member 90extending therefore and having an arcuate shape. The first and secondextension members 88 and 90 are operatively connected at point “P,” suchthat in operation the second extension member 90 travels through thefirst extension member 88 about an arcuate path and substantiallythrough point “P.” The arcuate shapes of the first and second extensionmembers 88 and 90 results in the foot rotating about the orthosis axis86, or alternatively about a moving IAR, when the second member 84 ismoved from a first position to a second position relative to the firstmember 82, there by preventing compression of the joint.

The orthosis 80 further includes a drive assembly 92 located at or nearpoint “P.” In this embodiment, the drive assembly 92 is operablyconnected to the first and second extension members 88 and 90 forapplying force to the first and second members 82 and 84 to pivot thesecond body portion about the orthosis axis 86.

In order for the orthosis 80 to flex the joint the first and secondmembers 82 and 84 are affixed to the first and second body portions,respectively, tightly enough so that the first and second members 82 and84 can apply torque to flex the joint. The second extension member 90 ismoved through the drive assembly 92 from a first position to a secondposition, relative to the first extension member 88, rotating the secondmember 84 and the second body portion about the orthosis axis 86stretching the joint. As the second member 84 is rotated to the secondposition, the second extension member 90 travels at least partiallythrough point “P” and may travel substantially through this point for alarge range of motion. Because the first and second members 82 and 84are affixed to the first and second body portions, the outward pivotingmovement of the second member 84 causes the joint to be flexed asdesired. The orthosis 80 may then be maintained in the second positionfor a predetermined treatment time providing a constant stretch to thejoint. The orthosis may alternatively be configured to impart a constantforce or load on the joint or may utilize the techniques of StaticProgressive Stretch as described in co-pending application Ser. No.11/203,516, entitled “Range of Motion System and Method”, and filed onAug. 12, 2005, the entirety of which is incorporated by reference.

Returning to the example where the orthosis is maintained in the secondposition, after the expiration of the treatment time, the second member84 may then be moved back to the first position, relieving the joint.Optionally, the second member 84 can be rotated to a third position,increasing the stretch on the joint, or partially reducing it to allowlimited relaxation of the surrounding tissue. The second member 84 canbe rotated at discrete time intervals to incrementally increase, reduce,or vary the stretch of the joint through the treatment cycle. Aftercompletion of the treatment cycle, the second member 84 is returned tothe first position for removal of the orthosis 80. In operation of theorthosis 80 can be utilized to flex the joint in either dorsiflexion orplantarflexion.

The first member 82 includes a cuff 94 having a pair of straps 96attachable about a user's lower leg. The straps 96 are sufficientlytighten to prevent relative movement between the first member 82 and thelower leg. The cuff 94 can be adjustably mounted to the first member 82to accommodate different size legs. A knee strap 98 is provided toassist in maintaining the orthosis 80 position and orientation on thelower leg. The knee strap 98 is mounted to a top portion of the firstmember 82, such that when a user's leg is positioned though the strap,the strap is disposed about a lower end of the thigh of a user, proximalto the knee joint. The strap 98 can be utilized to prevent the lower legfrom sliding up the device and also to be used to prevent heel lift-off.

Referring also FIG. 11, the first extension member 88 portion of thefirst member 82 includes an arcuate main channel 100 extending therein.A cover plate 102 is affixable to the first extension member 88, overthe main channel 100, defining a passage through which the secondextension member 90 travels. The first extension member 88 can furtherinclude a base 104, where the base 104 is configured to support theorthosis 80 on a flat surface.

Referring to FIG. 12, the drive assembly 92 is positioned in the firstextension member 88 portion of the first member 82, proximal to the base104. The drive assembly 92 includes drive gear 106 and a main gear 108,where the drive gear 106 and the main gear 108 are affixed to a driveaxle 110. (See also FIG. 13). The main gear 108 is positioned in thefirst extension member 88, and covered by the cover plate 102. The driveaxle 110 extends through the cover plate 102, where the drive gear 106is affixed to the drive axle 110

A worm gear 112 is positioned in engagement with the drive gear 106,such that a rotation of the worm gear 112 rotates the drive gear 106 andsubsequently the main gear 108. A drive shaft 114 is connected to theworm gear 112, extending the drive assembly 92. A knob 116 can beaffixed to the drive shaft 114 to facilitate rotation thereof. Arotation of the dive shaft 114 rotates the worm gear 112, which in turnrotates the drive and main gears 106 and 108. The main gear 108 is sizedsuch that a portion of the gear teeth 118 protrudes into the mainchannel 100 of the first extension member 88 portion of the first member82. The gear teeth 118 sufficiently protrude into the main channel 100,such that the gear teeth 118 can engage the second extension member 90.A drive cover 121 can be connected to the cover plate 102, where thedrive and worm gear 106 and 112 are covered by the drive cover 121. Theworm gear 112 is rotatably supported in the drive cover 121 inengagement with the drive gear 106. The worm gear 112 can be utilized toprevent a backing off of the drive assembly, decreasing the stretch ofthe connective tissue of the joint.

The drive mechanism 92 can further include a locking mechanism. Thelocking mechanism can be used to secure the position of the secondmember 84 with respect to the first member 82. The locking mechanism canprevent the actuation of the drive mechanism 92, securing the positionof first and second members 82 and 84. Alternatively, the lockingmechanism can secure the first and second members 82 and 84, preventingan actuation of the drive mechanism 92 from moving the first and secondmembers 82 and 84. The locking mechanism can be utilized such that theorthosis 80 can be used as a static splint.

Referring to FIGS. 12 and 13, the second extension member 90 of thesecond member 84 includes a lower surface 120, where the upper surface120 can include a plurality of teeth 122. The teeth 122 are sized suchthat the gear teeth 118 of the main gear 108 can engage the secondextension member 90 and move the second extension member 90 through thepassage in the first extension member 88 as the knob 116 is rotated.

The second member 94 can include a foot plate 124 slidingly mountedthereon. Referring to FIG. 14, the second member 84 can include aslotted section 126. A foot plate mounting bracket 128 is slidinglypositioned on the second member 84, about the slotted section 126. Pins130 are applied to slidingly secure the mounting bracket 128 in theslotted section 126. A threaded member 132 can be threaded through themounted bracket 128, into contact with the slotted section 146, where atightening of the threaded member 132 can be used to secure the positionof the mount bracket 126. As previously disclosed, the foot plate 124can further include a strap attachable about a user's foot. The strap issufficiently tightened to prevent relative movement between the footplate 124 and the foot. The slidingly mounting of the foot plate 124 tothe second member permits the foot plate to be adjustable to accommodatevarious size feet.

In an exemplary use, the orthosis 80 is operated to flex a joint indorsiflexion in the following manner. The first member 82 is fastened tothe lower leg and the second member 84 is fastened to the foot. Theorthosis 80 is attached to the first and second body portions in a firstposition. The drive assembly 92 is operated to move the second member 84from the first position to a second position, relative to the firstmember 82 by rotating the foot about a joint axis 86, wherein the secondextension member 90 is drawn into the first extension member 88. Theconnective tissue of the joint is consequently stretched. The orthosis80 is maintained in the second position for a predetermined treatmenttime, utilizing the principles of stress relaxation to stretch theconnective tissue of the joint. Additionally, the second extensionmember 90 can be made of a substantially rigid but flexible material,such that while in the second position the second extension member 90acts like a spring, providing dynamic stretch to the connective tissueof the joint. After the expiration of the treatment time, the secondmember 84 may be returned to the first position, relieving the joint.

Optionally, the second member 84 can be rotated to a third position,further increasing the stretch of the connective tissue of the joint.The second member 84 can be rotated at discrete time intervals toincrementally increase the stretch of the joint through the treatmentcycle. After completion of the treatment cycle, the second member 84 isreturned to the first position relieving the joint.

In an exemplary use, the orthosis 80 is operated to flex a joint inplantarflexion the following manner. The first member 82 is fastened tothe lower leg and the second member 84 is fastened to the foot. Theorthosis 80 is attached to the first and second body portions in a firstposition. The drive assembly 92 is operated to move the second member 84from the first position to a second position, relative to the firstmember 82 by rotating the second body portion about a joint axis 86,wherein the second extension member 90 is extended from the firstextension member 88. The connective tissue of the joint is consequentlystretched. The orthosis 80 is maintained in the second position for apredetermined treatment time, utilizing the principles of stressrelaxation to stretch the connective tissue of the joint. Additionally,the second extension member 90 can be made of a substantially rigid butflexible material, such that while in the second position the secondextension member 90 acts like a spring, providing dynamic stretch to theconnective tissue of the joint. After the expiration of the treatmenttime, the second member 84 may be returned to the first position,relieving the joint.

Optionally, the second member 84 can be rotated to a third position,further increasing the stretch of the connective tissue of the joint.The second member 84 can be rotated at discrete time intervals toincrementally increase the stretch of the joint through the treatmentcycle. After completion of the treatment cycle, the second member 84 isreturned to the first position relieving the joint.

Referring to FIG. 15, the orthosis 80 can further include a toe assembly140 attached to the foot plate 124. It is understood by those skilled inthe art that the other joints of the toe assembly 140 may be flexed orextended the toe, without departing from the spirit and scope of thedisclosure. Additionally, the toe assembly 140 is described in use onthe “big” toe or hallux on the foot. However, it should be understood bythose skilled in the art that the toe assembly 140 is equally applicablefor use on the second, third, fourth and minimus toes of the foot.

Each toe in the foot extends from the metatarsal bone and is formed bythe proximal phalanx, middle phalanx, and distal phalanx, each of whichis respectively pivotally connected to form a joint there between. Thetoe assembly 140 may be configured to flex or extend (or both) a toejoint, where the joint defines an inner sector on the flexor side thatdecreases in angle as the joint is flexed (bent) and an outer sector onthe extensor side that decreases in angle as the joint is extended(straightened). The toe assembly 140 may be configured as described inco-pending application Ser. No. 11/261,424, entitled “Range of Motion,”filed on Oct. 28, 2005, and PCT International Application No.PCT/US06/60228, entitled “Range of Motion Device,” filed on Oct. 27,2008 the entirety of which are incorporated by reference.

Referring to FIGS. 16-17, a toe assembly 140 of the present disclosureincludes a first member 142 affixable to the foot plate mounting bracket128 and a second member 144 having a toe cuff 146 attachable to a toe ofthe user's foot, wherein the second member 144 is rotatable with respectto the first member 142 about an axis of rotation 148. The toe cult 146can be sized to attach to a single toe or multiple toes. The first andsecond members 142 and 144 are attached to the foot and toe of the user,such that as the second member 144 is rotated about the axis of rotation148, the toe is rotated about a joint axis.

A first extension member 150 is affixed to and extends from the firstmember 142, wherein a drive assembly 152 is positioned on an end portionof the first extension member 150. A second extension member 154 issimilarly affixed to and extends from the second member 144, wherein thesecond extension member 154 has an arcuate shape. The second extensionmember 154 engages the drive assembly 152 of the first extension member150 at a point “P.” An actuation of the drive assembly 152 operates tomove the second extension member 154 through the drive assembly 152,such that the toe cuff 146 travels along an arcuate path with respect tothe first member 142. The arcuate shape of the second extension member154 results in the toe rotating about the joint axis, as the toe cuff146 is moved along the arcuate path “A.” the drive assembly 152 can beactuated to move the toe cuff 146 and toe from a first position to asecond position relative to the foot plate 124. Once again, the term“cuff” as used herein means any suitable structure for transmitting theforce of the toe assembly 140 to the limb portion it engages.

The first extension member 150 can extend substantially vertically fromthe first member 142 or extend at an angle .alpha. from the first member142, where the angle .alpha. and the radius of curvature of the secondextension member 154 (if constant) can be configured such that the axisof rotation 148 is aligned with the joint axis of rotation. Thecurvature of the second extension member 154 need not be constant, andtherefore the axis of rotation may shift or move in a manner thatpreferably mimics or approximates the moving IAR the joint wouldnormally have. Another potential benefit of the toe assembly 140 havingthe capability of a moving IAR is when multiple joints are being treatedby the device. For instance, the range of motion of the tip of a toe mayinvolve cooperative motion of two or more joints. If the combinedbending of the multiple joints causes the overall motion to rotate abouta moving axis, it would be beneficial for the toe assembly 140 toapproximate this moving IAR. Thus, the curvature of the second extensionmember 154 may be complex in order to better approximate a moving IAR.

Referring to FIG. 18, the drive assembly 152 can include a housing 156having a worm gear 158 therein. A first miter gear 160 is attached tothe worm gear 158 such that a rotation of the first miter gear 160rotates the worm gear 158. The drive assembly 152 further includes adrive shaft 162 have a knob 164 at one end and a second miter gear 166at an opposite end. The second miter gear 166 is positioned within thehousing 156, in engagement with the first miter gear 160. A rotation ofthe knob 165 rotates the drive shaft 162 and the second miter gear 166,which in turn rotates the first miter gear 160 and the worm gear 158.

A gear surface 168 of the second extension member 154 includes aplurality of teeth 170. The second extension member 154 is positionedthroughout the housing 156, such that the worm gear 158 engages theteeth 170 of the second extension member 154. A rotation of the knob 164rotates the worm gear 148, which in turn moves the second extensionmember 154 through the housing 156.

In an exemplary use, toe assembly 140 is operated to rotate a toe abouta joint axis in the following manner. The foot plate 124 is fastened tothe foot with one or more straps, laces, or similar retaining device.Similarly, the toe cuff 146 is fastened securely to the toe of the user,such that the joint and joint axis 148 is interposed between the footplate 124 and the toe cuff 146. The toe assembly 140 is attached to thetoot and toe in a first position. The drive assembly 152 is actuated tomove the second extension member 154, such that the toe cuff 146 travelsalong an arcuate path from the first position to a second position,relative to the foot plate 124, rotating the toe about the joint axisstretching the joint. The toe assembly 140 is maintained in the secondposition for a predetermined treatment time providing a constant stretchto the joint. Additionally, the second extension member 154 can be madeof a substantially rigid but material, such that while in the secondposition the second extension member 154 acts like a spring, providingdynamic stretch to the connective tissue of the joint.

After the expiration of the treatment time, the toe cuff 146 is movedback to the first position, relieving the joint. Optionally, the toecuff 146 can be rotated to a third position, thereby increasing ordecreasing the stretch on the joint. The toe cuff 146 can be rotated atdiscrete time intervals to incrementally increase the stretch of thejoint through the treatment cycle. After completion of the treatmentcycle, the toe cuff 146 is returned to the first position for removal ofthe toe assembly 140.

Referring to FIG. 19, the second extension member 154 can include anattachment bracket 171 for adjustably attaching the toe cuff 146 to thesecond extension member 154. The attachment bracket 171 can include atoe rod 172 extending there from. The toe cuff 146 can be slideablymounted on the toe rod 172 to position toe cuff 146 over the toe.Alternatively, the toe rod 172 can be of sufficient length such that thetoe cuff 146 can be slidingly positioned on a selected toe on the footof the user, for example, the big toe, minimus toe, or any toe therebetween.

The toe cuff 146 can be positioned on the toe rod 172 with a firstbracket 174, where the toe rod 172 passes through a passage 176 in thefirst bracket 174. A set screw 178 is provided to secure the firstbracket 174 to the toe rod 172. When the set screw 178 is loosened, thefirst bracket 174 is free to slide along the toe rod 172. A tighteningof the set screw 178 secures the first bracket 174 in place on the toerod 172.

The toe cuff 146 can further include a second bracket 180, where thesecond bracket 180 can be pivotally mounted to the first bracket 174.For example, the second bracket 180 can be attached to the first bracket174 with a pin or screw connector, allowing the second bracket 180 torotate with respect to the first bracket 174.

Additionally, when a joint is flexed or extended a compressive force maybe applied to the connective tissue surrounding the joint. It may bedesirable to control the compressive force, distracting the joint as thejoint is flexed or extended. “Distraction” is defined by one dictionaryas “separation of the surfaces of a joint by extension without injury ordislocation of the parts.” (Taber's Cyclopedic Medical Dictionary, 16thEdition, 1989, page 521), and involves stretching rather thancompressing the joint capsule, soft tissue, ligaments, and tendons.

Additionally, the second bracket 180 can be slideably mounted to thefirst bracket 174. For example the second bracket 180 can be mounted tothe first bracket 174 with a dovetail joint 182, allowing the secondbracket 180 to slide with respect to the first bracket 174. The slidingmovement of the toe cuff 146 helps to limit the distractive orcompressive forces which can be imparted on the joint by the rotation ofthe toe cuff 146 with respect to the foot plate 124.

The attachment bracket 171 can be mounted to the second extension member154 with a dovetail joint 184, where the attachment bracket 171 includesupper and lower joint section 186 and 188. The upper and lower jointsections 186 and 188 allow the attachment bracket 171 to be attached tothe second extension member 154 in either a flexed or extensionposition. Additionally, the dove tail joint 184 allows the attachmentbracket 171 to slide with respect to the second extension member 154.The sliding movement of the attachment bracket 171 helps to limit thedistractive or compressive forces which can be imparted on the joint bythe rotation of the toe cuff 146 with respect to the foot plate 124. Aset screw 190 is positionable through the attachment bracket 171,engaging the second extension member 154, such that the set screw 190can be used to control the position of the attachment bracket 171 withrespect to the second extension member 154.

The adjustable connection of the toe cuff 146 to the attachment bracket171 and the adjustable connection of the attachment bracket 171 to thesecond extension member 154 can be used to align the toe cuff 146 withthe toe. The alignment of the toe cuff 146 on the toe can be used tosubstantially limit the force applied to the toe to that of a torqueabout the joint axis 148.

In operation of the toe assembly 140 to extend the joint, the toeassembly 140 starts at a more flexed position. The attachment bracket171 is attached to the second extension member 154 such that the toecuff 146 engaged the toe of the user for movement in extension. The footplate 124 and toe cuff 146 are attached onto the foot and toe portions,respectively. The second extension member 154 is moved through the driveassembly 150 from the first position to a second position, relative tothe first extension member 142, rotating the toe cuff 146 and the toeabout the axis 148 stretching the joint. As the toe cuff 146 is rotatedto the second position the second extension member 154 travels along anarcuate path about and substantially through point “P.” The toe assembly140 is maintained in the second position for a predetermined treatmenttime providing a constant stretch to the joint.

As the toe assembly 140 is rotated from the first position to the secondposition, extending the joint, the toe cuff 146 moves along the firstbracket 174. Because the foot plate 124 and toe cuff 146 are clampedonto the foot and toe as described above, the outward pivoting movementof the toe cuff 146 causes the joint to be extended as desired. However,this extension of the joint can place strong distractive forces on thesoft tissues around the joint. The sliding movement of the toe cuff 146helps to limit these distractive forces by counteracting the outwardmovement. Thus, the detrimental effects of strong distractive forcesnormally generated in forced extension of a joint are avoided, beingreplaced with the beneficial effects of limited and controlleddistraction.

In operation of the toe assembly 140 to flex the joint, the toe assembly140 starts at a more extended position. The attachment bracket 171 isattached to the second extension member 154 such that the toe cuff 146engages the toe of the user for movement in flexion. The foot plate 124and toe cuff 146 are attached onto the foot and toe portions,respectively. The second extension member 154 is moved through the driveassembly 150 from the first position to a second position, relative tothe first extension member 142, rotating the toe cuff 146 and the toeabout the axis 148 stretching the joint. As the toe cuff 146 is rotatedto the second position the second extension member 154 travels along anarcuate path about and substantially through point “P.” The toe assembly140 is maintained in the second position for a predetermined treatmenttime providing a constant stretch to the joint.

As the toe assembly 140 is rotated from the first position to the secondposition, extending the joint, the toe cuff 146 moves along the firstbracket 174. Because the foot plate 124 and toe cuff 146 are clampedonto the foot and toe as described above, the inward pivoting movementof the toe cuff 146 causes the joint to be flexed as desired. However,this flexion of the joint can place strong compressive forces on thesoft tissues around the joint. The sliding movement of the toe cuff 146helps to limit these compressive forces by counteracting the inwardmovement. Thus, the detrimental effects of strong compressive forcesnormally generated in forced flexion of a joint are avoided, beingreplaced with the beneficial effects of limited and controlledcompression.

Referring to FIG. 20, the drive assembly 152 can be adjustable mountedto the first extension member 150. The first extension member 150includes a longitudinal slotted section 200. A threaded member 202 ispositioned through the longitudinal slotted section 200, where thethreaded member 202 is threaded into a threaded hole 204 in the driveassembly 152. The position of the drive assembly 152 is secured on thefirst extension member 150 by tightening the threaded member 202,compressing the first extension member 150 between the threaded member202 and the drive assembly 152. The position of the drive assembly 152can be adjusted by loosening the threaded member 202 and sliding thedrive assembly 152 along the longitudinal slot 200. In this manner theposition of the drive assembly 152 can be adjusted to align the axis ofrotation 148 with the joint axis.

The drive assembly 220 can further includes an indented portion 206. Theindented portion 206 in sized to receive the first extension member 150therein, such that the first extension member 150 slides through theindented portion 206 as the drive assembly 152 is moved along the firstextension member 152. The indented portion 206 is configured to alignthe drive assembly 152 with respect to the first extension member 150.The indented portion 206 provides the further benefit of resisting arotation of the drive assembly 152 with respect to the first extensionmember 150 when the toe assembly 140 is in use.

Referring to FIG. 21, the drive assembly 152 can include a pair ofindented portions 206 and 208, positioned on opposite sides on the driveassembly 152. As shown in FIG. 20, the first indented section 206 can beused to position the drive assembly 152 in an outer position on the toeassembly 140, where the drive assembly 152 is positioned on an outsidesurface 151 of the first extension member 150.

Alternatively, as shown in FIG. 22, the second indented section 208 canbe used to position the drive assembly 152 in an inner position on thetoe assembly 140, where the drive assembly 152 is positioned on an innersurface 153 of the first extension member 150. The threaded member 202is positioned through the longitudinal slotted section 200, where thethreaded member 202 is threaded into a second threaded hole 214 in thedrive assembly 152.

In an embodiment, the first member 142 can be adjustable mounted to thefoot plate 124, such that the position of the toe cuff 146 can beadjusted to align the toe cuff 146 with a toe of interest and the jointaxis of the toe. In instances were the joint of a toe is misaligned, forexample for toe deformations such as hammer toe, bunion, etc, the linearand angular position of the toe cuff 146 can be adjusted with respect tothe foot plate 124 aligning the toe cuff 146 with the misaligned toesuch that the axis of rotation 148 of the toe assembly 140 is alignedwith the axis of rotation of the toe joint. In the manner, the toeassembly 140 can be adjusted to prevent the unwanted application oftorsional forces to the toe joint.

Referring to FIG. 23, the first member 142 is adjustably attached to abottom surface of the foot plate 124. The first member 142 includes asecond, substantially horizontal, extension member 143 having alongitudinal slot 218, through which a pair of threaded members 220 and222 are positioned, attaching the first member 142 to the foot plate124, second extension member 143 can be moved along the longitudinalslot 218 to laterally adjust the position of the first member 142 withrespect to the foot plate 124. The first member 142 is secured inposition by tightening the threaded member 220 and 222, compressing thesecond extension member 143 between the threaded members 220 and 222 andthe bottom surface 216 of the foot plate 124.

The second extension member 143 can further include a secondlongitudinal slot 224, parallel and offset from the first longitudinalslot 218. The second extension member 143 can be attached to the footplate 124, using the second longitudinal slot 224 to longitudinallyadjust the position of the first member 142 with respect to the footplate 124. Similarly, the second extension member 143 can be moved alongthe second longitudinal slot 224 to laterally adjust the position of thefirst member 142 with respect to the foot plate 124.

It is also contemplated that the angular position of the first member142 can be adjusted with respect to the foot plate 124. In anembodiment, as shown in FIG. 24, the bottom surface 216 of the footplate 124 includes a center threaded hole 226 and an arcuate slot 228.An internally threaded fastener 230 is slidingly positioned in thearcuate slot 228, opposite the bottom surface 216. The first member 142is attached to the foot plate 124 by positioning the threaded members220 and 222 through a longitudinal slot 218 or 224 of the secondextension member 143 and engaging the threaded hole 226 and theinternally threaded fastener 230 in the arcuate slot 228. The angularposition of the first member 142 can be adjusted with respect to thefoot plate 124 by pivoting the second extension member 143 aboutthreaded member 220 in the center threaded hole 226, such that theinternally threaded fastener 230 and the second threaded member 220travel along the arcuate slot 228. The first member 142 is secured inposition by tightening the threaded members 220 and 222, compressing thesecond extension member 143 between the threaded members 220 and thebottom surface 216 of the foot plate 124, and compressing the secondextension member 143 and foot plate 124 between threaded member 222 andinternally threaded fastener 230.

The bottom surface 216 of the foot plate 124 can further include asecond arcuate slot 232, where an internally threaded fastener 234 isslidingly positioned in the second arcuate slot 232, opposite the bottomsurface 216 of the foot plate 124. Similar to arcuate slot 228, secondarcuate slot 232 can be used to angularly adjust the position of thefirst member 143 with respect to the foot plate 124.

Specifically, the first member 142 is attached to the foot plate 124 bypositioning the threaded members 220 and 222 through a longitudinal slot218 or 224 of the second extension member 143 and engaging the threadedhole 226 and the internally threaded fastener 234 in arcuate slot 232.The angular position of the first member 142 can be adjusted withrespect to the foot plate 124 by pivoting the second extension member143 about threaded member 220 in the center threaded hole 226, such thatthe internally threaded fastener 234 and the second threaded member 222travel along the arcuate slot 232. The first member 142 is secured inposition by tightening the threaded member 220 and 222, compressing thesecond extension member 143 between the threaded members 220 and thebottom surface 216 of the foot plate 124, and compressing the secondextension member 143 and foot plate 124 between the threaded member 222and internally threaded fastener 234.

It is also contemplated that the first member 142 can be attached to thefoot plate 124 using the arcuate slots 228 and 232 and the respectedinternally threaded members 230 and 234. Specifically, the first member142 is attached to the foot plate 124 by positioning the threadedmembers 220 and 222 through a longitudinal slot 218 or 224 of the secondextension member 143 and engaging the internally threaded fastener 230in the arcuate slot 228 and the internally threaded fastener 234 inarcuate slot 232. The angular position of the first member 142 can beadjusted with respect to the foot plate 124 by pivoting the secondextension member 143 such that the internally threaded fasteners 230 and234 travel along the arcuate slots 228 and 232. The first member 142 issecured in position by tightening the threaded member 220 and 222, thesecond extension member 143 and foot plate 124 between the treadedmembers 220 and 222 and internally threaded fastener 230 and 234.

While the embodiment discussed above utilize a second extension memberhaving an arcuate shape to control movement of the second member, itshould be understood that skilled artisans having the benefit of thisdisclosure will appreciate that other configurations may likewiseprovide similar relative movement.

The components of the present disclosure are rigid members made of, forexample, aluminum, stainless steel, polymeric, or composite materials.The member and extensions are sufficiently rigid to transmit thenecessary forces. It should be understood that any material ofsufficient rigidity might be used. For example, some components can bemade by injection molding. Generally, for injection molding, tool anddie metal molds of the components are prepared. Hot, melted plasticmaterial is injected into the molds. The plastic is allowed to cool,forming components. The components are removed from the molds andassembled.

Furthermore, it is contemplated that the components can be made ofpolymeric or composite materials such that the device can be disposable.For example, at least some or all of the components can be made of abiodegradable material such as a biodegradable polymer. Among theimportant properties of these polymers are their tendency todepolymerize relatively easily and their ability to form environmentallybenign byproducts when degraded or depolymerized. One such biodegradablematerial is poly (hydroxyacids) (“PHA's”) such as polyactic acid (“PLA”)and polyglycolic acid (“PGA”).

Additionally the device can be made of a nonmagnetic material. In suchinstance, the device can be used as a positioning device for use inimaging devices, such as a MRI device. It is also contemplated that thedevice can be used as a positioning device for use during surgicalprocedures, where it may be necessary to adjust and hold the position ofthe joint.

All references cited herein are expressly incorporated by reference intheir entirety.

It will be appreciated by persons skilled in the art that the presentdisclosure is not limited to what has been particularly shown anddescribed herein above. In addition, unless mention was made above tothe contrary, it should be noted that all of the accompanying drawingsare not to scale. A variety of modifications and variations are possiblein light of the above teachings without departing from the scope andspirit of the invention.

What is claimed is:
 1. An orthosis for stretching tissue about an anklejoint of a patient comprising: a first member configured to be securedto a lower leg of the patient; a second member movably connected to thefirst member and configured to be secured to a foot of the patient, thesecond member including a gear; and a drive assembly coupled to the gearof the second member, the drive assembly configured to drive movement ofthe gear to move the second member with respect to the first member,wherein movement of the second member relative to the first member atleast one of flexes and extends the ankle joint when the first member issecured to the lower leg of the patient and the second member is securedto the foot of the patient.
 2. The orthosis set forth in claim 1,wherein the first member includes a first arm and a lower leg cuffsecured to the first arm.
 3. The orthosis set forth in claim 2, whereinthe second member includes a second arm and a foot plate secured to thesecond arm.
 4. The orthosis set forth in claim 3, wherein the second armis movable connected to the first arm.
 5. The orthosis set forth inclaim 1, wherein drive assembly includes a drive gear rotatably mountedon the first member and operably coupled to the gear of the secondmember.
 6. The orthosis set forth in claim 5, wherein the drive gear ismanually rotatable for selectively moving the second member with respectto the first member.
 7. The orthosis set forth in claim 6, wherein thedrive gear includes a worm.
 8. The orthosis set forth in claim 7,wherein the drive assembly includes a knob for manually rotating thedrive gear.
 9. The orthosis set forth in claim 8, wherein the wormengages the gear of the second member.
 10. The orthosis set forth inclaim 9, wherein the drive assembly include a drive shaft secured to theknob.
 11. The orthosis set forth in claim 1, wherein the drive assemblyincludes a locking assembly.
 12. The orthosis set forth in claim 1,further comprising a toe orthosis attached to the second member.
 13. Theorthosis set forth in claim 12, wherein the toe orthosis includes a toecuff sized and shaped to engage a toe of the user.
 14. The orthosis setforth in claim 13, wherein the toe orthosis includes a toe driveassembly configured to drive movement of the toe cuff relative to thesecond member such that the toe cuff imparts movement of the toe of theuser during use of the toe orthosis.